Enhanced neurostimulation for treating anorexia nervosa
Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
This study is testing two brain stimulation treatments to see if they can help people with anorexia nervosa feel better and improve their eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT05788042 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and acceptability of two non-invasive brain stimulation techniques, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), in patients with anorexia nervosa. Participants will be randomly assigned to receive either active or sham versions of these treatments in a double-blinded manner. The study will take place at the Northside Clinic in Sydney, which specializes in eating disorders and has a high admission rate. The goal is to determine which method is more beneficial for improving psychological and eating disorder symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 and older with a current diagnosis of anorexia nervosa who are willing to comply with study requirements.
Not a fit: Patients who may not benefit include those with contraindications to tDCS/rTMS or those who have not responded to previous rTMS treatments.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from anorexia nervosa.
How similar studies have performed: Preliminary studies have shown promise for non-invasive brain stimulation techniques in treating anorexia nervosa, but this approach is novel in its direct comparison of tDCS and rTMS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥16 years, * A current Diagnostic and Statistical Manual of Mental Disorders (5th edition DSM-5) diagnosis of anorexia nervosa * Willing and able to participate and comply with study requirements * Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing) * Under ongoing care by his/her own treating psychiatrist (to ensure patient safety during the study) Exclusion Criteria: * Inability to provide informed consent * Contraindications to tDCS/rTMS * Failed to respond to an adequate course or rTMS (4 weeks) within the current illness course * Had ECT in the last 3 months * MoCA score of \<26 * Significant risk of significant self harm or suicide as assessed by study psychiatrist(s) * Currently enrolled in another interventional clinical trial or using an investigational device/product
Where this trial is running
Sydney, New South Wales
- Northside Clinic — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Sloane Madden, Assoc. Prof. — University of Sydney, Ramsay Health Care
- Study coordinator: Donel Martin, Dr
- Email: donel.martin@unsw.edu.au
- Phone: 02 9382 8353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.